Evidence map›Paper›PMID 29804268›Full record

Trial reportAnnals of hematology2018

Ruxolitinib for the treatment of inadequately controlled polycythemia vera without splenomegaly: 80-week follow-up from the RESPONSE-2 trial.

Martin Griesshammer, Guray Saydam, Francesca Palandri, Giulia Benevolo, Miklos Egyed, Jeannie Callum, Timothy Devos, Serdar Sivgin, Paola Guglielmelli, Caroline Bensasson and 3 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of hematology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Observational
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Volumetric Splenomegaly in Patients With Polycythemia Vera.Journal of Korean medical science · 2022
    Article
  14. Review
  15. Molecular pathogenesis of the myeloproliferative neoplasms.Journal of hematology & oncology · 2021
    Review
  16. Review
  17. Review
  18. Review
  19. Polycythemia Vera (PV): Update on Emerging Treatment Options.Therapeutics and clinical risk management · 2021
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Martin GriesshammerDepartment of Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Clinic, Minden, Germany. martin.griesshammer@muehlenkreiskliniken.de.
Guray SaydamDepartment of Hematology, Ege University Medical Faculty, Izmir, Turkey.
Francesca PalandriInstitute of Hematology "Seràgnoli", St. Orsola-Malpighi Hospital, Bologna, Italy.
Giulia BenevoloDepartment of Hematology, Città della Salute e della Scienza di Torino, Turin, Italy.
Miklos EgyedHematology Department of Somogy County, Kaposi Mor Teaching Hospital, Kaposvar, Hungary.
Jeannie CallumDepartment of Transfusion Medicine and Tissue Banks, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Timothy DevosDepartment of Hematology, University Hospitals Leuven and Laboratory of Experimental Transplantation, Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.
Serdar SivginDepartment of Hematology, Dedeman Stem Cell Transplantation Hospital, Erciyes University, Kayseri, Turkey.
Paola GuglielmelliCRIMM, Center for Research and Innovation of Myeloproliferative Neoplasms, AOU Careggi, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Caroline BensassonNovartis Pharma S.A.S, Rueil-Malmaison, France.
Mahmudul KhanNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Julian Perez RoncoNovartis AG, Basel, Switzerland.
Francesco PassamontiDepartment of Hematology, University of Insubria, Varese, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

RESPONSE-2 is a phase 3 study comparing the efficacy and safety of ruxolitinib with the best available therapy (BAT) in hydroxyurea-resistant/hydroxyurea-intolerant polycythemia vera (PV) patients without palpable splenomegaly. This analysis evaluated the durability of the efficacy and safety of ruxolitinib after patients completed the visit at week 80 or discontinued the study. Endpoints included proportion of patients achieving hematocrit control (< 45%), proportion of patients achieving complete hematologic remission (CHR) at week 28, and the durability of hematocrit control and CHR. At the time of analysis, 93% (69/74) of patients randomized to ruxolitinib were receiving ruxolitinib; while in the BAT arm, 77% (58/75) of patients crossed over to ruxolitinib after week 28. No patient remained on BAT by week 80. Among patients who achieved a hematocrit response at week 28, the probability of maintaining response up to week 80 was 78% in the ruxolitinib arm. At week 80, durable CHR was achieved in 18 patients (24%) in the ruxolitinib arm versus 2 patients (3%) in the BAT arm. The safety profile of ruxolitinib was consistent with previous reports. These data support that ruxolitinib treatment should be considered also as a standard of care for hydroxyurea-resistant/hydroxyurea-intolerant PV patients without palpable splenomegaly.

Indexed as

AgedCross-Over StudiesDrug Resistance, NeoplasmFemaleFollow-Up StudiesHematocritHumansMaleMiddle AgedNitrilesPhlebotomyPolycythemia VeraPyrazolesPyrimidinesSplenomegalyTreatment OutcomeNitrilesPyrazolesPyrimidinesruxolitinibChronic myeloproliferative disordersJAK inhibitorPolycythemia veraRuxolitinib

Identifiers

PMID29804268
PMCPMC6097748

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.